AU2007218014A1

AU2007218014A1 - Catheter cleaning devices

Info

Publication number: AU2007218014A1
Application number: AU2007218014A
Authority: AU
Inventors: Alan L. Buchman
Original assignee: Individual
Current assignee: Individual
Priority date: 2006-02-17
Filing date: 2007-02-14
Publication date: 2007-08-30
Also published as: US7922701B2; IL193493A; KR101414762B1; BRPI0708063A2; WO2007097985A2; US20080132880A1; EP1991291A4; IL193493A0; EP1991291A2; JP2009526617A; CA2642540A1; WO2007097985A3; CN101405042B; JP5185833B2; WO2007097985A8; ZA200807745B; SG169997A1; CA2642540C; CN101405042A; KR20080113211A

Description

WO 2007/097985 PCT/US2007/003994 1 CATHETER CLEANING DEVICES This application relates generally to the field of medicine and more specifically to catheter devices. BACKGROUND OF THE INVENTION 5 Central venous catheters (CVCs) are indispensible devices for medical practice, particularly among critically ill patients, cancer patients, and those that receive intravenous feeding. These devices allow for the rapid infusion of concentrated medications, fluids, or blood products that can otherwise not be administered via a standard intravenous catheter inserted into a peripheral extremity vein. Although such catheters supply necessary vascular access, they also 10 put the patient at risk for significant infection, which can be life-threatening. There are an estimated 3 million CVCs inserted each year in the USA and 200,000 in Great Britain (Little and Palmer, Nursing Standard 12:42-44, 1998). In the USA, such catheters remain in place for an estimated 15 million catheter days (1 catheter in I patient for I day = I catheter day) in ICUs alone (Mermel, Ann. Intern. Med. 132:391-402 (2000). Catheter-related 15 bloodstream infection is the most frequent cause of hospital-acquired bacteremia (Valles et al. Clin. Infect. Dis. 24:387-395 (1997). 80,000-400,000 central venous catheter (CVC)-related bloodstream infections (CRBI) occur in the USA annually, hospital stay is prolonged by an average of a week, and 2,400- 60,000 patients die (Mermel, Ann. Intern. Med. 132:391-402 (2000); Raad and Darouiche, Curr. Opin. Crit.Care 2:361-3651996; Arnow et al., Clin. Infect. 20 Dis. 16:778-784 (1993); CDC, National Nosocomial Infections Surveillance System (NNIS) report, data summary from October 1986-April 1998, issued June, 1998. Am. . Infect. Control 26:522-533, (1998); Digiovine et al., Am. J. Respir. Crit. Care Med. 160:976-981 (1999); Rello et al., Am. J. Respir. Crit. Care Med. 162:1027-1030 (2000); Soufir et al., Infect. Control Hosp. Epidemiol. 20:396-401 (1999); Kluger and Maki, Abstracts of the 39th Interscience Conference 25 on Antimicrobial Agents and Chemotherapy. San Franciso, CA: American Society for Microbiology, 514 (1999)). Estimates of the annual cost of caring for the CVC-related infections in these patients ranged from $296 million to $2.3 billion in 2000 (Mermel, Ann. Intern. Med. 133:395 (2000)). The use of needleless catheter devices has been associated with an increased risk for bloodstream infection (Kellerman et al., J. Pediatr. 129:711-717 (1996); Do et al., J 30 Infect. Dis. 179:442-448, (1999)).

WO 2007/097985 PCT/US2007/003994 2 Most catheter-related bloodstream infections (CRBI) associated with the use of long-term catheters (>10 days) stem from endoluminal contamination and subsequent colonization of the catheter hub. The hub may become contaminated when microorgansims are present on the external hub surface from contact with the patient's skin, tracheostomy secretions, wounds, 5 ostomy and feces, and the like, or from transfer to the hub surface from the physician or nurse manipulating the catheter (Cicco et al., Lancet 2:1258-1260 (1989)). Most episodes of CRBI are caused by coagulase negative staphylococci, Staphylococcus aureus, enterococci species, Klebsiellapneumonia,-Escherichia coli, and Candida species (CDC. Guidelines for the prevention of intravascular catheter-related infections. MMWR 51:1-29, (2002)). 10 The catheter hub (junction of the catheter and intravenous tubing) has been identified as the primary source of CRBI in patients that have an indwelling catheter for >10 days (Sitges Serra and Linares, Lancet 1:668 (1983); Sitges-Serra et al., Surgery 97:355-257 (1985); Sitges Serra et al., JPEN 8:668-672 (1984); Linares et al., J. Clin. Microbiol. 21:357-360 (1985); Forse et al., Surgery 86:507-514 (1979); Moro et al., Infect. Control Hops. Epidemiol. 15:253-264 15 (1994); Llop et al., Clin. Nutr. 20:527-534 (2001); Bouza et al., J. Hosp. Infect. 54:279-287, (2003); Salzman and Rubin, Nutrition 13:15S-17S (1997); Tan et al., J. Infect. Dis. 169:1393 1397 (1994)). The hub is often contaminated during manipulation necessary to draw blood samples, administer medication, fluid, or parenteral nutrition. Microorganisms present on or nearby (ostomy, wound, fistula, skin, tracheostomy, blanket/clothing) the external hub surface 20 are transferred to the hub lumen by the patient's, nurse's, or physician's fingers when the catheter hub is handled (De Cicco et al., Lancet 2:1258-1260 (1989)). Even 10-20% of piggyback side ports punctured six times daily become colonized with pathogenic microorganisms (Brismar et al., Clin. Nutr. 6:31-36 (1982). Current hub designs were designed primarily to ensure a tight connection with 25 intravenous tubing, but were not designed specifically to prevent hub and endoluminal catheter microbial colonization. Prevention of hub colonization, and therefore of hub-mediated infections is dependent on the avoidance of contamination during connection/disconnection of tubing, during direct injections, and during blood drawing as well as protection against contamination of the hub while connected to tubing. Experimental evidence has shown that intentional hub 30 surface bacterial contamination leads to 100% internal fluid pathway contamination in an inappropriately disinfected hub and that disinfection of the hub cap will prevent up to 99% of potential contamination of the internal fluid pathway (Ardulno et al., Am. J. Infect. Control 26:377-380 (1997)). Needleless systems now in current use may also result in increased WO 2007/097985 PCT/US2007/003994 3 infection risk when compared to previous needled systems (Danzig et at., JAMA 273:1862-1864 (1995); Kellerman et al., J. Pediatr. 129:711-717 (1996)). These systems differ from older needle-containing systems by nature of their hub design. Therefore, prevention of hub colonization will reduce or prevent the introduction of 5 microorganisms into the catheter lumen. Such prevention may be evoked through careful cleaning and preparation of the catheter prior to use. Often however, such care is less than optimal and, in an emergency situation especially, catheter hubs are not often cleaned appropriately (Stotter et al., JPEN 11:159-162 (1987); Sitges-Serra, Support Care Cancer 7:391 395 (1999)). Neither the currently used Luer-lock connector or the rubber membrane 10 "piggyback" system have anti-microbial properties and therefore require strict aseptic manipulation. In addition, proper hub care requires additional training and increases the time required for already constrained health care professionals. Thus, there exists a need for techniques and devices that can be effective at reducing microbial contamination of a catheter connection. The present invention satisfies this need and 15 provides related advantages as well. SUMMARY OF INVENTION The invention provides an injection port cap, comprising a body having a cavity extending from a distal end to a proximate end of the body; a movable frit located within the cavity so as to form a reservoir between the frit and the proximate end of the body; a biasing 20 element arranged to urge the movable frit towards the distal end of the body; and an absorbent element located within the cavity adjacent the distal end of the body. The invention also provides a catheter cleaning device comprising a body comprising a passageway extending from a proximate opening adjacent a proximate end to a distal end; a penetrable sealing element located adjacent the proximate end within the passageway; an 25 absorbent element located within the passageway between the distal end and the penetrable sealing element; at least one brush located between the penetrable sealing element and the absorbent element; a luer connector located within the passageway between the distal end and the brushes; and a reservoir formed within the passageway between the luer connector and the penetrable sealing element. 30 The invention additionally provides a catheter cleaning injection port cap, comprising a body comprising a passageway extending from a proximate end to a distal end; the proximate WO 2007/097985 PCT/US2007/003994 4 end operable in a closed position and an open position; the body further comprising an actuating member configured to change the proximate end from the closed position to the open position; a plurality of separable absorbent elements located within the passageway adjacent the proximal end; and a fluid impermeable sheath covering at least a portion of an exterior of the body. 5 BRIEF DESCRIPTION OF THE DRAWINGS The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawings will be provided by the Office upon request and payment of the necessary fee. Figure 1 shows an exemplary catheter cleaning device as a cap design. The cap is made 10 up of two parts, the body 10 and the connector/top 20 as shown in Figure 1. The other parts include mobile frit 30, open cell wiping foam or sponges 40, O-ring 50, and spring 60. Frit 30 forms a reservoir 70 in the cavity of body 10. Figure 2 shows an exemplary catheter cleaning device as a penetration design. The parts that make up the port of the penetration design include device body 110 with luer threads 15 included for attachment to the central venous catheter (CVC) and the feeding tube or male luer. The other parts include the bottom plug 120 that is in the male luer to the CVC, piston 130, scrubbing memory open cell foam 140, scrubbing brushes 150 and sealing foam 160. Figure 3 shows an exemplary catheter cleaning device as a pop open design. The pop open cap design is made up of three parts, the device body 210, the fluid sheath 220, and 20 scrubbing/bathing foam 230. Also shown is a separate luer activated needleless valve/port/connector 240. The position depicted is the "closed" position. Figure 4 shows the catheter cleaning device shown in Figure 3 depicted in the "open" position. Figure 5 shows an exemplary catheter cleaning device in section view. 25 Figure 6 shows a side view of an exemplary catheter cleaning device. Figure 7 shows a top view of an exemplary catheter cleaning device. Figure 8 shows an exemplary catheter cleaning device in the "open" position, with a measurement of the open position shown.

WO 2007/097985 PCT/US2007/003994 5 Figure 9 shows an exemplary male luer with measurement of its diameter. Figure 10 shows a male luer entering an exemplary catheter cleaning device. Figure 11 shows a male luer locked into an exemplary catheter cleaning device. Figure 12 shows a top view of a male luer inserted and locked into an exemplary catheter 5 cleaning device. DETAILED DESCRIPTION OF THE INVENTION The present invention provides catheter cleaning devices that are effective at reducing microbial contamination of a catheter port entry. The catheter cleaning devices of the invention reduce the potential for introducing infection into a patient via a catheter port entry. The catheter 10 cleaning devices of the invention reduce microbial contamination at a catheter port entry by continually cleaning the port entrance by bathing it in an antimicrobial solution. The catheter cleaning devices also incorporate scrubbing surfaces that function to scrub the catheter connection as well as apply antimicrobial solution. Thus, the catheter port is bathed in antimicrobial solution, keeping the parts aseptic and clean. 15 As disclosed herein, a device has been developed that is designed to be used with a needleless intravenous system that will ensure the catheter hub is always disinfected regardless of the technique used to connect the catheter or lack of catheter care. This device also decreases the incidence of hub contamination, catheter lumen microbial colonization, and therefore, the risk for CRBI. This antimicrobial barrier effectively prevents endoluminal catheter contamination. A 20 previous hub model that incorporated a chamber of 3% iodinated alcohol into which a needle would pass prior to insertion into the catheter was effective in the prevention of endoluminal catheter microbial colonization both in vitro and in vivo (Segura et al., J. Clin. Microbiol. 27:2656-2659 (1989); Segura et al., J. Clin. Microbiol. 28:2551-2554 (1990); Segura et al., Ann. Surg. 223:363-369 1996)). 25 Based on the results of a meta-analysis of eight studies and several more recent investigations, results have shown that skin preparation with chlorhexidine (0.5% or 10% chlorhexidine gluconate alcohol solution or 0.5% or 2% chlorhexidine gluconate aqueous solution) is more effective than 10% povidone-iodine for prevention of bacterial colonization and CRBI (Chaiyakunapruk et al., Ann. Intern. Med. 136:792-801 (2002); Maki et al., Grit. Care 30 Med. 28:A42 (2000); Garland et al., Pediatrics 107:1431-1436 (2001); Casey et al., J. Hosp.

WO 2007/097985 PCT/US2007/003994 6 Infect. 54:288-293 (2003)), current standard of care now includes disinfection of the catheter hub with chlorhexidine (Northwestern Memorial Hospital (NMH) nursing protocol; Inoue et al., JPEN 16:581-585 (1992); Bouza et al., J. Hosp. Infect. 54:279-287 (2003)). The catheter cleaning devices of the invention are intended to reduce colonization of the 5 bacteria that reside on the surface of the needleless injection port entry area. When the mating luer fitting is inserted into the port, a person with a central venous catheter (CVC) has to clean the entry port up to 42 times per week. Every time this is done there is a slight chance that bacteria will be introduced into the patients venous system. Improper cleaning of the port entry area allows the bacteria to enter the port. The present invention reduces the bacteria available for 10 accidental insertion by continually bathing the needleless port in an antimicrobial solution such as isopropyl alcohol (IPA) and chlorhexidine (CHG) mix. This solution has been shown to be very effective against bacteria and other microorganisms. Currently hospitals generally use a procedure to simply wipe the area of the port with three ChloraprepTM one-step wipes. These wipes are not easy to use on small objects and it is 15 very subjective as to who and how the ports are cleaned in determining how well the bacteria count is reduced. Improper, hurried, or sloppy cleaning procedures will lead to a greater chance of bacterial ingress. As used herein, a "bloodstream infection" refers to a blood culture that is positive for microbes such as bacterial or fungal microorganisms. 20 As used herein, a "catheter-related bloodstream infection" or "CRBI" refers to the occurrence of a bloodstream infection in a patient with a central venous catheter (CVC) in whom another source of infection is not wound, urine, respiratory, or intra-abdominal in origin. As used herein, "catheter endoluminal colonization" refers to the presence of viable microorganisms such as bacteria or yeast, which can be grown in culture, on the inside walls of a 25 catheter in the absence of positive blood cultures or any septic focus. As used herein, a "catheter hub" refers to the junction between the intravenous catheter and intravenous tubing or other connection device. In one embodiment, the invention provides a catheter cleaning device that is a cap design. The cap design for a catheter cleaning device is screwed on to a standard luer fitting of a 30 needleless injection port.

WO 2007/097985 PCT/US2007/003994 7 An exemplary catheter cleaning device that is a cap design contains a body 10 and a connector/top 20, as shown in Figure 1. The body 10 and connector/top 20 can be ultrasonically welded or adhesively joined together, for example, during final assembly after all the other parts are installed. The other parts of a catheter cleaning device that is a cap design include mobile frit 5 30 for slow transfer of cleaning solution, open cell scrubbing surface such as a wiping foam or sponges 40 to clean the port threads, O-ring 50 to seal the solution into its reservoir and a spring 60 to push frit 30 distally when the device is not installed onto a port. Reservoir 70 is for an antimicrobial solution such as IPA and CHG antimicrobial cleaning solution. The device cleans the CVC needleless port by screwing onto the luer fitting and pushing the mobile frit 30 up into 10 reservoir 70. The increased pressure in the reservoir forces the solution through the frit 30 and into the foam 40, which in turn bathes the port opening in the antimicrobial solution and has a scrubbing action on the luer top, injection port piston, and threads. When a male luer is to be attached to a catheter, this device is removed, but can be tethered to the CVC port by an optional strap that runs between connector/top 20 and the port. The spring 60, during removal of the 15 device, pushes the frit 30 out, creating a slight vacuum, which draws the solution back into reservoir 70. This vacuum limits the amount of solution evaporation when the cap is not installed onto a luer fitting. When the cap is then reattached to the luer, the frit 30 is again forced into reservoir 70 and the solution is forced into frit 30 and foam 40, re-bathing the needleless port in antimicrobial solution. As the frit 30 is pushed further into reservoir 70, the device can 20 optionally contain a window to observe a visual indicator, in which O-ring 50, which can be colored to facilitate visualization, can be visualized through a clear section on the side of body 10, indicating the antimicrobial solution is low in volume and a new cap should be installed. The frit 30 and scrubbing foam 40 and the positive pressure on tie antimicrobial cleaning solution continually bathe the port entrance. The negative pressure from the reservoir limits evaporation 25 of the cleaning solution when not attached to the catheter port. In one embodiment, the invention provides a catheter cleaning device, comprising a body having a cavity; a movable frit disposed in the cavity, whereby the frit is positioned to form a reservoir in the cavity; a spring disposed in the reservoir; an o-ring disposed between the frit and the wall of the cavity; and a scrubbing foam disposed in the cavity proximal to the frit and distal 30 to the reservoir. The catheter cleaning device can further comprise a window positioned to indicate the position of the frit in the cavity. The catheter cleaning device can further comprise an antimicrobial solution dispersed in the reservoir.

WO 2007/097985 PCT/US2007/003994 8 In another embodiment, the invention provides an injection port cap, comprising a body having a cavity extending from a distal end to a proximate end of the body; a movable frit located within the cavity so as to form a reservoir between the frit and the proximate end of the body; a biasing element arranged to urge the movable frit towards the distal end of the body; and an 5 absorbent element located within the cavity adjacent the distal end of the body. In such an injection port cap, the frit can be comprised of a porous material. In an injection port cap of the invention, the biasing element can comprise a spring, for example, a helical spring, which can be located within the reservoir. An injection port cap of the invention can contain an absorbent element comprising a sponge. 10 In an embodiment of an injection port cap of the invention, the frit can be configured to provide a fluid pathway between the reservoir and the absorbent element. The liquid in the reservoir of an injection port cap can be forced through the frit to the absorbent element when the frit is moved against the biasing element towards the proximate end of the body. Generally, the cavity of the injection port cap of the invention has a substantially cylindrical shape. 15 In an injection port cap of the invention, the absorbent element can be located along at least a portion of a circumference of the cavity adjacent the distal end of the body. The body of an injection port cap can further comprise a window positioned to indicate a position of the frit or to indicate the level of liquid in the reservoir. In an injection port cap, the cavity can comprise a closed end at the proximate end of the 20 body and an opening at the distal end of the body. In such an injection port cap, the reservoir can be located between a top surface of the frit and the closed end of the cavity. Generally, the opening of the cavity of an injection port cap is sized to accommodate a catheter. In a particular embodiment, the opening of the cavity can further comprise screw threads adjacent the distal end of the body, for example, where the screw thread are configured to accommodate a luer fitting of 25 a needleless injection port. In an injection port cap of the invention, the cap can further comprise a sealing member located between a side surface of the frit and an inner surface of the cavity. For example, the sealing member can comprise an elastomer o-ring located around the side surface of the frit. An injection port cap of the invention can further comprise an antimicrobial solution located within 30 the reservoir.

WO 2007/097985 PCT/US2007/003994 9 In another embodiment, the invention provides a catheter cleaning device having a penetration design. The penetration design for a catheter cleaning device replaces the current needleless injection port with an all in one design. This device has the needleless injection port system included in the design. 5 An exemplary catheter cleaning device having a penetration design has parts that make up the port, which include device body 110 with luer threads included for attachment to the central venous catheter (CVC) and the feeding tube or male luer (see Figure 2). The other parts include bottom plug 120 that is in the male luer to the CVC and piston 130 that is compressed to allow fluid flow. The new parts of the device are the scrubbing surface/memory open cell foam 140, 10 scrubbing brushes 150 to assist cleaning of the incoming luer and displacement of scrubbing surface 140, and sealing foam 160 to retain solution and protect against evaporation. Sealing foam 160 should remain moist and antimicrobial. Reservoir 170 contains antimicrobial solution. The catheter cleaning device having a penetration design replaces the standard needleless port of the CVC so that the entrance to the catheter by the top of the piston 130 is continually 15 bathed in antimicrobial solution such as IPA/CHG solution. When the male luer connector is needed, it is pushed through the sealing foam 160, brushes 150, and scrubbing foam 140 and screwed onto the female luer fitting. The scrubbing foam 140, sealing foam 160 and brushes 150 are pushed to the radial sidewalls, and the antimicrobial solution is displaced into the reservoir 170. When the male luer is removed, the scrubbing foam 140 resumes its position and covers the 20 port opening and bathes it in an antimicrobial solution such as IPA/CHG solution. The brushes 150 and sealing foam 160 also resume their original positions to seal out the microbes. The antimicrobial solution re-penetrates brushes 150, scrubbing foam 140, and sealing foam 160, cleaning them and making them anti-microbial surfaces. The scrubbing foam 140, sealing foam 160, and brushes 150 of the device protect the catheter entrance from microbial ingress. 25 In another embodiment, the invention provides a catheter cleaning device, comprising a body having a cavity; a plug disposed in the cavity; a piston positioned proximal to the plug in the cavity; a scrubbing foam proximal to the piston; brushes proximal to the scrubbing foam; a seal proximal to the brushes; and a reservoir in the cavity adjacent to the scrubbing foam, whereby insertion of a male luer allows penetration through the scrubbing foam, brushes and seal 30 and displacement of fluid into the reservoir. The catheter cleaning device can further comprise an antimicrobial solution dispersed in the scrubbing foam and brushes.

WO 2007/097985 PCT/US2007/003994 10 In yet another embodiment, the invention provides a catheter cleaning device comprising a body comprising a passageway extending from a proximate opening adjacent a proximate end to a distal end; a penetrable sealing element located adjacent the proximate end within the passageway; an absorbent element located within the passageway between the distal end and the 5 penetrable sealing element; at least one brush located between the penetrable sealing element and the absorbent element; a luer connector located within the passageway between the distal end and the brushes; and a reservoir formed within the passageway between the luer connector and the penetrable sealing element. In such a catheter cleaning device, the luer connector can be a female luer connector. The penetrable sealing element of a catheter cleaning device can 10 comprise absorbent foam. In a catheter cleaning device of the invention, the penetrable sealing device can be configured to operate in a first position when a luer fitting is inserted within the proximate opening and in a second position when no luer fitting is inserted within the proximate opening. For example, the penetrable sealing element can compress radially when operating in the first 15 position. The penetrable sealing device can be configured to reduce evaporation of a fluid within the passage way operating in the second position. In a catheter cleaning device of the invention, the absorbent element can include a central opening having a major axis substantially in-line with a major axis of the passageway. An inner surface of the absorbent element along its central opening can be configured to contact a luer 20 fitting positioned adjacent the luer connector. In another emodiment, a bottom portion of the absorbent element can be located adjacent a top portion of the luer connector. The absorbent element of a catheter cleaning device of the invention can be at least partially impregnated with antimicrobial solution. The absorbent element of a catheter cleaning device can be configured to radially compress when a luer fitting is attached to the luer connector 25 such that a portion of the antimicrobial solution travels from the absorbent element to the reservoir. The portion of the antimicrobial solution in the reservoir can be located adjacent to an interface between the luer fitting and the luer connector. A catheter cleaning device can further comprise a piston located within the passageway and extending from the luer connector through the distal end of the body. In a catheter cleaning 30 device, the penetrable sealing element can comprise foam. The absorbent element can comprise open cell foam.

WO 2007/097985 PCT/US2007/003994 11 In yet another embodiment, the invention provides a catheter cleaning device that has a pop open design. The pop open design for a catheter cleaning device bonds the newly designed cap to a currently produced luer activated needleless injection port/connector. This new combination unit is used instead of the current plain injection port on the CVC catheters. 5 An exemplary catheter cleaning device having a pop open cap design has the device body 210, the fluid sheath 220, and scrubbing surface/bathing foam 230, as shown in Figure 3, depicted in the "closed" position. The body device 210 contains bumped sides that can be compressed so that the device body 210 is in the "open" position (depicted in Figure 4). The only other part in this design is the commercially available luer activated needleless 10 valve/port/connector 240. The bathing foam 230 has a membrane to limit evaporation of the cleaning solution that permeates the foam. Two pieces of bathing foam 230, approximate half cylinders, are bonded to the device body 210 with the membrane side facing out or externally. This assembly is then bonded and sealed onto the commercially available needleless valve such that the foam parts are in contact with the needleless valve opening. This proximity will allow 15 scrubbing foam 230 to scrub the valve opening on actuation and closure of the cap/device. Also, the constant contact with the valve opening will allow continual bathing with the antimicrobial solution such as IPA and CHG solution. The next step is bonding the fluid sheath 220 to the external surface of the device body 210 along the base to prevent leakage of antimicrobial solution and along the spines on the body to ensure proper placement of the sheath. The fluid 20 sheath 220 and device body 210 can be ultrasonically welded or adhesively joined together. This sheath acts as a second skin that helps contain the antimicrobial solution, closes the cap end on luer port removal, and blocks debris from entering into the part when the luer port is installed. Finally the antimicrobial solution is added to the scrubbing foam 230 internal to the membrane. This final assembly is then used instead of a standard needleless port of the CVC so that 25 the entrance to the catheter by the top of the needless valve/port/connector 240 is continually bathed in antimicrobial solution. When a luer needs to be connected to the port, the device is squeezed on the bumped sides, which splits open the bathing foam scrubbers 230 and reveals the female luer fitting in a cleaned condition (see Figure 4). The male luer is inserted and the sides are released, enveloping the connection in a protected environment. Upon completion of 30 accessing the needleless valve, the male luer is unscrewed and removed, and the foam is compressed together over the needless valve opening, re-bathing it in antimicrobial solution until the next access is needed. This closed position also protects the valve opening from direct contamination from external sources. The foam 230 protects the entrance from microbial WO 2007/097985 PCT/US2007/003994 12 ingress. The device body is a firmer plastic and, when the sides of the device are squeezed, the plastic deforms, forcing the two halves of the device open and allowing access to the luer valve. The fluid sheath is made of a very elastic material that stretches open from the force imparted on it from the plastic device body as it deforms. 5 An exemplary catheter cleaning device is depicted in Figure 5. Such an exemplary catheter cleaning device is also referred to herein as a "cap" or "AB cap." An exemplary catheter cleaning device was produced, as shown in Figures 6-12 and described in Example II. In yet another embodiment, the invention provides a catheter cleaning device, comprising a body having a cavity and a compressible position; a scrubbing foam disposed in the cavity; 10 wherein the scrubbing foam has a fluid impermeable side that faces outward from the cavity, and a needleless port disposed in the cavity. Such a catheter cleaning device can further comprise an antimicrobial solution dispersed in the scrubbing foam. In still another embodiment, the invention provides a catheter cleaning injection port cap, comprising a body comprising a passageway extending from a proximate end to a distal end; the 15 proximate end operable in a closed position and an open position; the body further comprising an actuating member configured to change the proximate end from the closed position to the open position; a plurality of separable absorbent elements located within the passageway adjacent the proximal end; and a fluid impermeable sheath covering at least a portion of an exterior of the body. In such a catheter cleaning injection port cap, the absorbent elements can be impregnated 20 with an antimicrobial solution. The absorbent elements can form a substantially closed surface when the proximate end is operated in the closed position. The absorbent elements can be spatially separated from one another when the proximate end is operated in the open position. In a catheter cleaning injection port cap of the invention, the proximate end can be configured to accommodate a luer fitting when operated in the open position. One or more of the 25 absorbent elements can be configured to contact an exterior of a luer fitting being inserted in the proximate end. In a catheter cleaning injection port cap of the invention, the plurality of separable absorbent elements can include two substantially half cylindrical sponges, wherein the sponges are adjacent one another when the proximate end is operated in the closed position and separate from one another when the proximate end is operated in the open position. 30 The body of a catheter cleaning injection port cap of the invention can be constructed of a deformable material. The actuating member of a catheter cleaning injection port cap of the WO 2007/097985 PCT/US2007/003994 13 invention can comprise at least one compressible portion protruding radially outward from a major axis of the passageway. For example, when the at least one compressible portion is compressed, the proximate end is in the open position; and when the at least one compressible portion is uncompressed, the proximate end is in the closed position. The distal end of a catheter 5 cleaning injection port cap can be bonded to a needleless valve. For example, a bottom surface of the absorbent element is adjacent an opening of the needleless valve when the distal end is bonded to the needleless valve. The catheter cleaning devices of the invention can include antimicrobial solutions to clean and sanitize catheter port entries. In one embodiment, the antimicrobial solution is a mixture of 10 isopropyl alcohol and chlorhexidine or aqueous chlorhexidine. For example, the antimicrobial solution can contain about 0.05% to about 10% chlorhexidine gluconate (CHG), particularly about 0.05% to about 4%, for example, about 0.1%, about 0.2%, about 0.5%, about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9% or about 10%. A particularly useful antimicrobial solution is about 2% chlorhexidine in 70% isopropyl alcohol. 15 Other suitable alcohols can also be used or mixtures of alcohols. The alcohol generally ranges from about 50% to about 80%, in particular about 70% or 75% alcohol. Alternatively, an aqueous solution of chlorhexidine gluconate, in the range of about 0.5% to about 2% of CHG, can be used as an antimicrobial solution. Other suitable antimicrobial solutions include iodine and its derivatives, for example, iodinated alcohol, for example, 3% iodinated alcohol, and 20 povidone-iodine, for example, a 10% solution, or other suitable concentrations having antimicrobial activity. Other suitable antimicrobial solutions include silver sulfadiazine or other antiseptics. It is understood that mixtures of various antimicrobial agents can also be used. These and other antimicrobial solutions are well known to those skilled in the art (Segura-et al., J. Clin. Microbiol. 27:2656-2659 (1989); Segura et al., J. Clin. Microbiol. 28:2551-2554 (1990); 25 Segura et al., Ann. Surg. 223:363-369 1996); (Chaiyakunapruk et al., Ann. Intern. Med. 136:792 801 (2002); Maki et al., Crit. Care Med. 28:A42 (2000); Garland et al., Pediatrics 107:1431-1436 (2001); Casey et al., J. Hosp. Infect. 54:288-293 (2003)), Inoue et al., JPEN 16:581-585 (1992); Bouza et al., J. Hosp. Infect. 54:279-287 (2003)). While the catheter cleaning devices of the invention described above and depicted in 30 Figures 1-4 show specific embodiments, it is understood by those skilled in the art that modifications of the devices can be made so long as the catheter port connections are bathed in an antimicrobial solution and reduce microbial contamination of a catheter port entry. One WO 2007/097985 PCT/US2007/003994 14 skilled in the art can readily determine suitable modifications of the catheter cleaning devices of the invention. For any of the catheter cleaning devices of the invention, various modifications can be made to facilitate replenishment or dispersal of antimicrobial solution to appropriate places 5 within the device. For example, a valve system can be added to introduce fresh antimicrobial solution to the device in order to penetrate or cover the fits, foam, or surfaces of the devices. Optionally, the valve can have an aperture or iris, such as found in a camera, to seal off the valve top and clean it on opening. In addition, a pressure piston can be used to encourage fluid transfer to facilitate dispersal of the antimicrobial solution to needed locations within the device. In 10 addition, a screw mechanism or detent system can be included to create pressure to facilitate movement of the antimicrobial solution. This can serve to increase fluid capacity of the catheter cleaning devices of the invention, particularly in the cap design device. Vents can also be included on the catheter cleaning devices of the invention to help transfer fluid from a reservoir to materials to be contacted with the antimicrobial solution such as the foams that wipe the 15 threads for the cap design or the foam and brushes of the penetration design. In addition, a catheter cleaning device can include an additional reservoir of antimicrobial solution that can be used to replenish the solution available for cleaning catheter connections. For example, a reservoir can contain a seal or valve that allows infusion of antimicrobial solution into the device, for example, by holding the device in a particular position, or the solution can be infused by 20 squeezing a compressible reservoir. Such a reservoir can also be combined with the modifications described above to facilitate replenishment or dispersal of antimicrobial solution in the catheter cleaning device. Additional modifications of a catheter cleaning device of the invention can include foam formed around a needleless port to prevent additional loss of fluid. For example, the foam in the 25 device can have finger like projections that reach down to the end of the threads of the luer, closer to the cylindrical body of the luer body. The fingers can be lightly compressed on an area to catch any loose fluid in the device and help soak it into the main body of the foam. This could greatly help fluid loss if the device is activated when upside down. In addition, the scrubbing surface made of foam or sponge can be designed to plunge deeper into the device to help wick up 30 antimicrobial solution. In addition, coloration can be incorporated into the scrubbing surface or foam, or other components of the device, to help target the connecting luer into the appropriate position in the device. Furthermore, the foam can incorporate a color change that reflects evaporation of the antimicrobial solution, for example, evaporation of alcohol, which can be used WO 2007/097985 PCT/US2007/003994 15 to conveniently indicate a need to use a new device. In addition, modifications can be incorporated into specific devices suitable for the particular device. For a catheter cleaning device having a cap design, the device can include a threaded frit that can be used to limit over tightening and over pressurization of the reservoir. Furthermore, 5 the scrubbing surface/foam of the cap design can be omitted so as not to clean the threads of the luer fittings. In such a case, a seal is provided in place of the foam to retain the microbial solution in the device. Instead, the device provides antimicrobial solution to bathe the catheter connections without the scrubbing action of the foam. For a catheter cleaning device having a penetration design, a plastic cap can be included 10 to cover the opening to prevent evaporation and ingress of microbes. A catheter cleaning device having a penetration design can also include foam or sponges placed into the reservoirs to insure wicking action and full saturation of scrubbing foams. In addition, the scrubbing foams can optionally be omitted, relying on the brushes to seal and clean the port entrance. For a catheter cleaning device having a pop open design, colored targets on the sides of 15 the pop open device can be used to indicate where to push to activate/open the cap. The invention additionally provides a catheter cleaning device that is a wiping cap that is suitable to clean existing needleless catheter components. Such a wiping cap is a sealed cap with foam inserts approximating the size of the luer systems. As with the catheter cleaning devices of the invention, the foam can be saturated with antimicrobial solution to clean the ends of 20 needleless port. This design allows good coverage of the port entry area with antimicrobial solution. The device can be disposed of after each use, if desired. Such a device conveniently substitutes for the physical wiping of catheter ports as currently practiced by health care professionals and eliminates variability between health care professionals using current practice. In such a design, the open end can be covered by a cap to prevent evaporation of antimicrobial 25 solution prior to use. The invention also provides a catheter cleaning device, comprising a body having a cavity, the body having a closed end and an open end; a scrubbing foam disposed in the cavity, and an antimicrobial solution dispersed through the scrubbing foam. The invention further provides a method of adapting a luer activated needleless valve by 30 bonding a catheter cleaning injection port cap over an opening of the luer activated needleless valve. In a particular embodiment of the method, the catheter cleaning injection cap can WO 2007/097985 PCT/US2007/003994 16 comprises a body comprising a passageway extending from a proximate end to a distal end; the proximate end operable in a closed position and an open position; the body further comprising an actuating member configured to change the proximate end from the closed position to the open position; a plurality of separable absorbent elements located within the passageway adjacent the 5 proximal end; and a fluid impermeable sheath covering at least a portion of an exterior of the body. The invention additionally provides a method of inhibiting microbial infection in an individual by using a catheter cleaning device of the invention. The method is useful for inhibiting infection of an individual with non-viral, non-protozoal, non-mold human infectious 10 organisms. Thus, the method is useful for inhibiting or preventing infection at a catheter site by decreasing the likelihood of infection with Gram positive, Gram negative or non-mold fungi such as yeast. It is understood that modifications which do not substantially affect the activity the various embodiments of this invention are also provided within the definition of the invention 15 provided herein. Accordingly, the following examples are intended to illustrate but not limit the present invention. EXAMPLE I Testing of Catheter Cleaning Device for Reducing Microbial Contamination of a Catheter Port Entry 20 This example describes testing the effectiveness of the catheter cleaning devices. The outer portion a catheter cap of a CVC needleless port is swabbed with various amounts of microbial cultures. Particularly, representative microorganisms are selected from Gram positive, Gram negative and fungi. The microbial cultures tested are Staphylococcus aureus, Klebsiella pneumonia, Escherichia coli, Candida species such as Candida albicans. 25 Other microorganisms can similarly be tested, for example, Staphylococcus epidermidis, Klebsiellaplanticola, Pseudomonas aeruginosa, and the like. These and other human infectious microorganisms can be similarly tested. The testing involves swapping the outer portion of a catheter cap (the portion through which the male luer will pass) with 2000 cfu's (colony forming units) of bacteria or fungi. Other 30 amounts of microbial cultures can also be tested. Sterile tubing is connected to the device, using the male luer to the female portion contained within the device, for example with a catheter WO 2007/097985 PCT/US2007/003994 17 cleaning device having a penetration design. Saline is then infused and the effluent is plated and cultured to detect and quantify microbial growth. Similar experiments are conducted with other devices of the invention by swabbing with bacteria or fungi the outer portion of the catheter connection to be used with a particular device.. 5 The catheter is then connected, and saline is infused and collected. The effluent is cultured to detect and quantify microbial growth. EXAMPLE 11 Generation of a Catheter Cleaning Device This example describes the generation of an exemplary catheter cleaning device. Such a 10 device is also referred to as a "cap" or "AB cap." A catheter cleaning device or cap was designed to keep needleless luer valves clean by encapsulating them in a cleaning solution. A cap was attached to a standard production needleless luer valve that is able to be squeezed open for attachment of a male luer lock. The AB cap has three main components, the inner shell (white piece; see top view in Figure 7), the outer 15 membrane sheath (foggy clear exterior covering; see top view in Figure 7), and foam brushes (yellow interior; see top view in Figure 7). The AB cap was glued over a standard production needless luer valve, such as an InVision-Plus@ needless luer valve (RyMed Technologies, Inc.; Franklin TN). Any type of needless luer valve suitable for a catheter cleaning device can be used, including any other 20 manufacturers of needless luer valves. The foam brushes abut up to the entrance of the needless luer (see Figure 5). Based on the measurements of a typical threaded male luer lock and the opened AB cap, the luer easily passes into the device and reaches the plunger of the needleless luer valve (see Figures 6-12). Furthermore, Figure 8 shows that, with the luer open, the green plunger of the 25 needleless injection valve can easily be seen while the foam brushes of the AB cap, positioned laterally, are not in a position to interfere with the attachment of the male luer. Figures 10, 11 and 12 detail the male luer attachment to the needleless injection port and demonstrate that, once the AB cap is released, it envelopes the male luer until the process is reversed by removing the male luer.

WO 2007/097985 PCT/US2007/003994 18 Throughout this application various publications have been referenced. The disclosures of these publications in their entireties are hereby incorporated by reference in this application in order to more fully describe the state of the art to which this invention pertains. Although the invention has been described with reference to the exampled provided above, it should be 5 understood that various modifications can be made without departing from the spirit of the invention.

Claims

1. An injection port cap, comprising: a body having a cavity extending from a distal end to a proximate end of the body; 5 a movable frit located within said cavity so as to form a reservoir between the frit and the proximate end of the body; a biasing element arranged to urge the movable frit towards the distal end of the body; and an absorbent element located within the cavity adjacent the distal end of the body. 10

2. The injection port cap of claim 1, wherein the frit is comprised of a porous material.

3. The injection port cap of claim 1, wherein the biasing element comprises a spring.

4. The injection port cap of claim 1, wherein the biasing element comprises a helical spring.

5. The injection port cap of claim 1, wherein the biasing element comprises a helical 15 spring located within the reservoir.

6. The injection port cap of claim 1, wherein the absorbent element comprises a sponge.

7.. The injection port cap of claim 1, wherein the frit is configured to provide a fluid pathway between the reservoir and the absorbent element.

8. The injection port cap of claim 7, wherein a liquid in the reservoir is forced through 20 the frit to the absorbent element when the frit is moved against the biasing element towards the proximate end of the body.

9. The injection port cap of claim 1, wherein the cavity has a substantially cylindrical shape.

10. The injection port cap of claim 9, wherein the absorbent element is located along at 25 least a portion of a circumference of the cavity adjacent the distal end of the body. WO 2007/097985 PCT/US2007/003994 20

11. The injection port cap of claim 1, wherein the body further comprises a window positioned to indicate a position of the frit.

12. The injection port cap of claim 1, wherein the cavity comprises a closed end at the proximate end of the body and an opening at the distal end of the body. 5

13. The injection port cap of claim 12, wherein said reservoir is located between a top surface of the frit and the closed end of the cavity.

14. The injection port cap of claim 12, wherein the opening of the cavity is sized to accommodate a catheter.

15. The injection port cap of claim 12, wherein the opening of the cavity further 10 comprising screw threads adjacent the distal end of the body.

16. The injection port cap of claim 15, wherein the screw thread are configured to accommodate a luer fitting of a needleless injection port.

17. The injection port cap of claim 1, wherein the cap further comprises a sealing member located between a side surface of the frit and an inner surface of the cavity. 15

18. The injection port cap of claim 17, wherein the sealing member comprises an elastomer o-ring located around the side surface of the frit.

19. The injection port cap of claim 1, further comprising an antimicrobial solution located within the reservoir.

20. A catheter cleaning device comprising: 20 a body comprising a passageway extending from a proximate opening adjacent a proximate end to a distal end; a penetrable sealing element located adjacent the proximate end within the passageway; an absorbent element located within the passageway between the distal end and 25 the penetrable sealing element; at least one brush located between the penetrable sealing element and the absorbent element; WO 2007/097985 PCT/US2007/003994 21 a luer connector located within the passageway between the distal end and the brushes; and a reservoir formed within the passageway between the luer connector and the penetrable sealing element. 5

21. The catheter cleaning device of claim 20, wherein the luer connector is a female luer connector.

22. The catheter cleaning device of claim 20, wherein the penetrable sealing element comprises absorbent foam.

23. The catheter cleaning device of claim 20, wherein the penetrable sealing device is 10 configured to operate in a first position when a luer fitting is inserted within the proximate opening and in a second position when no luer fitting is inserted within the proximate opening.

24. The catheter cleaning device of claim 23, wherein the penetrable sealing element compresses radially when operating in the first position. 15 24 The catheter cleaning device of claim 23, wherein the penetrable sealing device is configured to reduce evaporation of a fluid within the passageway operating in the second position.

25. The catheter cleaning device of claim 20, wherein the absorbent element includes a central opening having a major axis substantially in-line with a major axis of the 20 passageway.

26. The catheter cleaning device of claim 25, wherein an inner surface of the absorbent element along its central opening is configured to contact a luer fitting positioned adjacent the luer connector.

27. The catheter cleaning device of claim 20, wherein a bottom portion of the absorbent 25 element is located adjacent a top portion of the luer connector.

28. The catheter cleaning device of claim 20, wherein the absorbent element is at least partially impregnated with antimicrobial solution. WO 2007/097985 PCT/US2007/003994 22

29. The catheter cleaning device of claim 28, wherein the absorbent element is configured to radially compress when a luer fitting is attached to the luer connector such that a portion of the antimicrobial solution travels from the absorbent element to the reservoir. 5

30. The catheter cleaning device of claim 29, wherein the portion of the antimicrobial solution in the reservoir is located adjacent to an interface between the luer fitting and the luer connector.

31. The catheter cleaning device of claim 20, further comprising a piston located within the passageway and extending from the luer connector through the distal end of the body. 10

32. The catheter cleaning device of claim 20, wherein the penetrable sealing element comprises foam

33. The catheter cleaning device of claim 20, wherein the absorbent element comprises open cell foam.

34. A catheter cleaning injection port cap, comprising: 15 a body comprising a passageway extending from a proximate end to a distal end; the proximate end operable in a closed position and an open position; the body further comprising an actuating member configured to change the proximate end from the closed position to the open position; a plurality of separable absorbent elements located within the passageway 20 adjacent the proximal end; and a fluid impermeable sheath covering at least a portion of an exterior of the body.

35. The catheter cleaning injection port cap of claim 34, wherein the absorbent elements are impregnated with an antimicrobial solution.

36. The catheter cleaning injection port cap of claim 34, wherein the absorbent elements 25 form a substantially closed surface when the proximate end is operated in the closed position. WO 2007/097985 PCT/US2007/003994 23

37. The catheter cleaning injection port cap of claim 34, wherein the absorbent elements are spatially separated from one another when the proximate end is operated in the open position.

38. The catheter cleaning injection port cap of claim 34, wherein the proximate end is 5 configured to accommodate a luer fitting when operated in the open position.

39. The catheter cleaning injection port cap of claim 34, wherein one or more of the absorbent elements are configured to contact an exterior of a luer fitting being inserted in the proximate end.

40. The catheter cleaning injection port cap of claim 34, wherein the plurality of 10 separable absorbent elements include two substantially half cylindrical sponges, wherein the sponges are adjacent one another when the proximate end is operated in the closed position and separate from one another when the proximate end is operated in the open position.

41. The catheter cleaning injection port cap of claim 34, wherein the body is constructed 15 of a deformable material.

42. The catheter cleaning injection port cap of claim 34, wherein the actuating member comprises at least one compressible portion protruding radially outward from a major axis of the passageway.

43. The catheter cleaning injection port cap of claim 42, wherein when the at least one 20 compressible portion is compressed, the proximate end is in the open position; and when the at least one compressible portion is uncompressed, the proximate end is in the closed position.

44. The catheter cleaning injection port cap of claim 34, wherein the distal end is bonded to a needleless valve. 25

45. The catheter cleaning injection port cap of claim 44, wherein a bottom surface of the absorbent element adjacent an opening of the needleless valve when the distal end is bonded to the needleless valve. WO 2007/097985 PCT/US2007/003994 24

46. A method of adapting a luer activated needleless valve, comprising the step of bonding a catheter cleaning injection port cap over an opening of the luer activated needleless valve.

47. The method of claim 46 wherein the catheter cleaning injection cap comprises: 5 a body comprising a passageway extending from a proximate end to a distal end; the proximate end operable in a closed position and an open position; the body further comprising an actuating member configured to change the proximate end from the closed position to the open position; a plurality of separable absorbent elements located within the passageway 10 adjacent the proximal end; and a fluid impermeable sheath covering at least a portion of an exterior of the body.

48. A catheter cleaning device, comprising a body having a cavity; a movable frit disposed in said cavity, whereby said frit is positioned to form a reservoir in said cavity; a spring disposed in said reservoir; an o-ring disposed between said frit and the wall of said 15 cavity; and a scrubbing foam disposed in said cavity proximal to said frit and distal to said reservoir.

49. The catheter cleaning device of claim 48, further comprising a window positioned to indicate the position of said frit in said cavity.

50. The catheter cleaning device of claim 48, further comprising an antimicrobial 20 solution dispersed in said reservoir.

51. A catheter cleaning device, comprising a body having a cavity; a plug disposed in said cavity; a piston positioned proximal to said plug in said cavity; a scrubbing foam proximal to said piston; brushes proximal to said scrubbing foam; a seal proximal to said brushes; and a reservoir in said cavity adjacent to said scrubbing foam, whereby insertion 25 of a male luer allows penetration through said scrubbing foam, brushes and seal and displacement of fluid into said reservoir.

52. The catheter cleaning device of claim 51, further comprising an antimicrobial solution dispersed in said scrubbing foam and brushes. WO 2007/097985 PCT/US2007/003994 25

53. A catheter cleaning device, comprising a body having a cavity and a compressible position; a scrubbing foam disposed in said cavity; wherein said scrubbing foam has a fluid impermeable side that faces outward from said cavity, and a needleless port disposed in said cavity. 5

54. The catheter cleaning device of claim 53, further comprising an antimicrobial solution dispersed in said scrubbing foam.

55. A catheter cleaning device, comprising a body having a cavity, said body having a closed end and an open end; a scrubbing foam disposed in said cavity, and an antimicrobial solution dispersed through said scrubbing foam.